Assembly for a flowable material container

ABSTRACT

The present invention provides a multiple layered non-PVC containing tubing structure. The tubing structure has a first and a second layer. The first layer is of a polymer blend of (a) from about 30% to about 50% by weight of the first layer a first polyolefin selected from the group consisting of a first propylene containing polymer, (b) from about 0 to about 50% by weight of the first layer a second polyolefin of an α-olefin containing polymer; (c) from about 0% to about 40% by weight of the first layer a radio frequency susceptible polymer selected from the group consisting of polyamides, ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, polyureas, ethylene vinyl acetate copolymers with a vinyl acetate comonomer content from 18-50% by weight of the copolymer, ethylene methyl acrylate copolymers with methyl acrylate comonomer content from 180%-40% by weight of the copolymer, ethylene vinyl alcohol with vinyl alcohol comonomer content from 15%-70% by mole percent of the copolymer; (d) from about 5% to about 40% of a first thermoplastic elastomer. The second layer is of a non-PVC containing material and is a multiple component polymer blend of from about 25% to about 55% by weight of a second thermoplastic elastomer, 20% to about 4:)% of a polyester polyether block copolymer, 0-15% ethylene copolymerized with vinyl lower alkyl esters, 0-10% of a second propylene containing polymer and from 0%-35% acrylonitrile butadiene styrene block copolymer.

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application is a continuation of Ser. No. 09/756,351 filedJan. 8, 2001, currently pending, which is incorporated herein byreference and made a part hereof.

FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] Not Applicable.

BACKGROUND OF THE INVENTION

[0003] 1. Technical Field

[0004] The present invention relates generally to closures for flowablematerial containers and more particularly closure assemblies for medicalfluid containers.

[0005] 2. Background of the Invention

[0006] It is common medical practice to provide fluids to a patienteither intravenously or enterally as a method of treating a patient forvarious medical conditions. Frequently, the fluids to be administered toa patient are contained in a flexible container. One method of forming aflexible container is to seal two sheets of flexible material about theperiphery of the sheets to create a fluid tight chamber. A port tubeassembly is frequently placed between the sheets during the sealingprocess to create a communication between the fluid chamber and theexterior of the container to provide a means of introducing fluid intoor dispensing fluid from the container. The port tube assembly typicallyincludes an outer port tube that attaches to the sidewalls of thecontainer and a second tube called a membrane tube that is disposedcoaxially within the port tube. The membrane tube has a membrane ordiaphragm that seals the port tube assembly. The membrane is typicallypunctured by a spike of a fluid administration set to place the contentsof the container in fluid communication with a patient.

[0007] Port tubes and membrane tubes are fabricated from monolayer ormultiple layered materials. The port tube typically has an inner layerof polyvinyl chloride and the membrane tube has an outer layer of PVC.To assemble the port tube assembly, the membrane tube is dipped incyclohexanone or other suitable solvent and is inserted in a telescopingfashion into the port tube. The solvent melts the PVC of both the porttube and the membrane tube thereby hermetically sealing the membranetube to the port tube.

[0008] There has been a great effort by many manufacturers of medicalarticles to replace PVC materials with non-PVC containing materials.Flexible PVC containers include low molecular weight additives know asplasticizers which may exude into the solutions contained in thecontainer. U.S. Pat. Nos. 5,998,019 and 5,849,843, which areincorporated herein by reference and made a part hereof, disclosereplacing PVC materials in medical fluid containers with non-PVCcontaining materials.

[0009] U.S. Pat. No. 5,356,709, assigned to the same assignee of thepresent invention, discloses a non-PVC coextruded medical grade porttubing. The tubing has an outer layer of a blend of polypropylene andSEBS a tie layer and a core layer of a blend of polyamide and EVA.

[0010] U.S. Pat. No. 5,533,992, assigned to the same assignee of thepresent invention, discloses a non-PVC material for fabricating medicaltubings and medical containers. Polymer blends for fabricating medicaltubing disclosed in the '992 patent include polyurethane blended withone or more of the following: EVA, SEBS, PCCE, and thermoplasticcopolyester elastomers.

[0011] The present assignee is presently marketing a container forstoring, shipping and delivering of medical fluids. A port tube providedwith the container has an outer layer of a polymer blend by weight ofthe following four compoents: 40% polypropylene, 40°/0 ultra low densitypolyethylene, 10% dimer fatty acid polymamide and 10%styrene-ethylene-butene-styrene block copolymer with maleic anhydridefunctionality. The port tubing has an inner layer of PVC for solventbonding to a membrane tube of PVC material.

SUMMARY OF THE INVENTION

[0012] The present invention provides a non-PVC port tube, a non-PVCmembrane tube and a non-PVC closure assembly for use in flowablematerial containers such as medical and food containers.

[0013] The closure assembly includes a port tube and a membrane tubecoaxially mounted therein. The port tube has a first layer and a secondlayer disposed coaxially within the first layer. In a preferred form ofthe invention the first layer is capable of being sealed to sidewalls ofa flowable materials container and more preferably using radio frequencysealing techniques. In a preferred form of the invention the first layeris a polymer blend of four components. The first component is present inan amount by weight of from about 25% to about 50% by weight of thefirst layer. The first component is a first polyolefin of a propylenecontaining polymer. The second component is present in an amount byweight of from about 0 to about 50% by weight of the first layer and isa second polyolefin. The second polyolefin is an α-olefin containingpolymer and in a preferred form of the invention is an ethylene andα-olefin copolymer. The third component is present in an amount byweight of from about 0% to about 40% by weight of the first layer and isa radio frequency (“RF”) susceptible. The RF polymer is selected fromthe group consisting of polyamides, ethylene acrylic acid copolymers,ethylene methacrylic acid copolymers, polyimides, polyurethanes,polyesters, polyureas, ethylene vinyl acetate copolymers with a vinylacetate comonomer content from 18-50% by weight of the copolymer,ethylene methyl acrylate copolymers with methyl acrylate comonomercontent from 18%-40% by weight of the copolymer, ethylene vinyl alcoholwith vinyl alcohol comonomer content from 15%-70% by mole percent of thecopolymer; and (4) from about 0% to about 40% of a first thermoplasticelastomer. Particularly suitable blends are disclosed in greater detailin U.S. Pat. No. 5,686,527 which is incorporated herein by reference andmade a part hereof.

[0014] The second layer of the port tube is disposed coaxially withinthe first layer and is a non-PVC material that is reactive with anorganic solvent. More preferably the second layer is reactive with anaromatic solvent including cyclohexanone, toluene, tetrahydofuran,cumene, xylenes, diethyl benzene decalin, tetralin and amyl benzene toname a few. In a preferred form of the invention the second layer is ablend of from about 25% to about 55% by weight of a thermoplasticelastomer, 20% to about 45% of a polyester polyether block copolymer,0%-15% ethylene vinyl acetate, 0-10% of a propylene containing polymerand from 0%-35% of a polymer selected from the group consisting ofacrylonitrile butadiene styrene block copolymer, styrene ethylene butenecopolymer, styrene acrylonitrile copolymer and cyclic olefin or bridgedpolycylic olefin containing polymers.

[0015] In one preferred form of the invention, the membrane tube has twolayers an outer layer and an inner layer disposed coaxially within theouter layer. The outer layer is reactive to organic solvents and morepreferably the aromatic solvents identified above. The outer layer ofthe membrane tube is of a material selected from the same materials asthe second layer of the port tube. Likewise, the inner layer of themembrane tube is capable of being sealed using radio frequency sealingtechniques and is selected from the same materials as set forth abovefor the first layer of the port tube.

[0016] The present invention also provides for membrane tubings havingmore than two layers, such as three layers or more. In a preferredembodiment, a core layer of a thermoplastic elastomer such as a styreneand diene type copolymer such as Kraton KG 2705 sold by Shell ChemicalCo.

[0017] These and other aspects and attributes of the present inventionwill be discussed with reference to the following drawings andaccompanying specification.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018]FIG. 1 is a cross-sectional view of a flexible material containerand a port closure assembly.

[0019]FIG. 2 is a cross-sectional view of a closure assembly having amembrane tube and two-layered port tube.

[0020]FIG. 3 is a cross-sectional view of a closure assembly having amembrane tube and a three-layered port tube.

DETAILED DESCRIPTION OF THE INVENTION

[0021] The present invention is susceptible of embodiments in manydifferent forms. Preferred embodiments of the invention are disclosedwith the understanding that the present disclosure is to be consideredas exemplifications of the principles of the invention and are notintended to limit the broad aspects of the invention to the embodimentsillustrated.

[0022]FIG. 1 shows a flowable material container 10 having sidewalls 12sealed along peripheral edges to define a chamber 14 therebetween. Aclosure assembly 16 provides access to the contents of the container.The container 10 is preferably fabricated from a non-PVC containingmaterial. In a preferred form of the invention the sidewalls 12 arefabricated from a multiple component polymer alloy disclosed in detailin U.S. Pat. No. 5,686,527 which is incorporated herein by reference andmade a part hereof. One particularly suitable polymer alloy is a blendof polypropylene, ultra-low density polyethylene, a dimer fatty acidpolyamide and a styrene and hydrocarbon block copolymer. The container10 shown in FIG. 1 is particularly suitable for medical applicationssuch as storage and delivery of IV solutions, peritoneal dialysissolutions, pharmaceutical drugs and blood and blood components to name afew. It is contemplated that such a container can also be used to storefood products or other consumable products.

[0023] What is meant by “flowable material” is a material that will flowby the force of gravity. Flowable materials therefore include bothliquid items and powdered or granular items and the like.

[0024]FIG. 2 shows the closure assembly 16. The closure assembly 16 hasa port tube 18 and a membrane tube 20 coaxially mounted therein. A fluidpassageway 21 of the membrane tube 20 is sealed by a membrane 22positioned at an intermediate portion of the membrane tube 20. Formedical applications, the membrane 22 can be punctured by a spike of aninfusion set to place the contents of the container into fluidcommunication with, for example, the vascular system of a patient beingtreated.

[0025] In a preferred form of the invention, the port tube 18 is amultilayered structure and more preferably has a first layer 23 and asecond layer 24. The first layer 23 should be of a non-PVC containingmaterial that is capable of being sealed to the sidewalls 12 of thecontainer 10, and preferably sealed using radio frequency sealingtechniques. In a preferred form of the invention, the first layer 23 isa polymer blend of: (a) from about 25% to about 50% by weight and morepreferably from about 30% to about 40% by weight, of the first layer afirst polyolefin selected from the group consisting of propylenecontaining polymers, (b) from about 0 to about 50% by weight, and morepreferably from about 5-40% by weight, of the first layer a secondpolyolefin of an α-olefin containing polymer or copolymer and morepreferably is an ethylene and α-olefin copolymer; (c) from about 0% toabout 40% by weight, and more preferably from about 10% to about 40% byweight, of the first layer a radio frequency susceptible polymerselected from the group consisting of polyamides, ethylene acrylic acidcopolymers, ethylene methacrylic acid copolymers, polyimides,polyurethanes, polyesters, polyureas, ethylene vinyl acetate copolymerswith a vinyl acetate comonomer content from 18-50% by weight of thecopolymer, ethylene methyl acrylate copolymers with methyl acrylatecomonomer content from 18%-40% by weight of the copolymer, ethylenevinyl alcohol with vinyl alcohol comonomer content from 15%-70% by molepercent of the copolymer; and (d) from about 0% to about 40% by weight,and more preferably from 10% to about 40% by weight, of the first layerof a thermoplastic elastomer.

[0026] One particularly suitable blend for the port tube first layer isa four component blend having by weight the following components: fromabout 10% to about 40% and more preferably 30% of a dimer fatty acidpolyamide, from about 0% to about 50% and more preferably from about 0%to about 10% of an ultra low density polyethylene, from about 25% toabout 50% and more preferably from about 30% to about 40% of apolypropylene and from about 10% to about 40% and more preferably 30%styrene-ethylene-butene-styrene block copolymer with maleic anhydridefunctionality.

[0027] The second layer 24 of the port tube 18 is of a non-PVCcontaining material that is capable of being solvent bonded to themembrane tube 20. In a preferred form of the invention, the second layer24 is a multiple component blend of the following components by weight:from about 25% to about 55% and more preferably from 33%-52% of athermoplastic elastomer, from about 20% to about 45% and more preferablyfrom about 25% to about 42% of a polyester polyether block copolymer,from about 0% to about 15% and more preferably from about 5% to about12% by weight of the second layer an ethylene copolymerized with vinyllower alkyl esters and preferably vinyl acetate, from about 0% to about10% by weight and more preferably from about 1% to about 5% by weight ofthe second layer of a propylene containing polymer and from about 0% toabout 35% by weight of a polymer selected from the group consisting ofacrylonitrile butadiene styrene (ABS) block copolymer, styrene ethylenebutene copolymer, styrene acrylonitrile copolymer and cyclic olefin orbridged polycylic olefin containing polymers.

[0028] One particularly suitable blend of the second layer 24 of theport tube is a five-component blend having from about 33% to about 35%SEBS (Kraton 1660), from about 25% to about 29% polyester polyetherblock copolymers (Hytrel), from about 5% to about 9% EVA, from about 1%to about 3% polypropylene and from about 28% to about 32% ABS.

[0029] Another suitable blend of the second layer of the port tube is afour-component blend having from about 48% to about 52% SEBS, from about36% to about 42% polyester polyether block copolymer, from about 8% toabout 12% EVA and from about 1% to about 4% polypropylene.

[0030] As shown in the Figures, the first layer 23 has a thicknessgreater than the second layer 24. In a preferred form of the invention,the first layer will have a thickness of from about 15 mils to about 40mils and more preferably from about 20 mils to about 30 mils. The secondlayer 24 will have a thickness from about 2 mils to about 12 mils andmore preferably from about 5 mils to about 10 mils.

[0031] The membrane tube 20 should be fabricated from a non-PVCcontaining material and should be capable of being bonded, preferablyusing solvent bonding techniques, to the port tube 18. In a preferredform of the invention, the membrane tube 20 is a multilayered structure.The membrane tube 20 has an outer layer 26 and an inner layer 28. Theouter layer 26 is of a material selected from the same materials as setforth for the second layer 24 of the port tube. Likewise the inner layer28 of the membrane tube 20 is selected from the same materials as thefirst layer 22 of the port tube 18.

[0032] A particularly suitable inner layer of the membrane tube is afour-component blend by weight of the inner layer 28 that slightlyvaries from the most preferred first layer of the port tube. Thecomponents are by weight of the inner layer 28 as follows: 40%polypropylene, 40% ultra-low density polyethylene, 10% polyamide and 10%SEBS. It should be understood, however, that the inner layer 28 of themembrane tube could also be selected from the same components and weightpercentage ranges as set forth above for the first layer of the porttube.

[0033] In a preferred form of the invention, the outer layer of themembrane tube should have a thickness from about 15 mils to about 35mils and more preferably from about 20 mils to about 30 mils. The innerlayer of the membrane tube should have a thickness from about 2 mils toabout 12 mils and more preferably from about 5 mils to about 10 mils.

[0034]FIG. 3 shows an alternate embodiment of the membrane tube havingthree layers. In addition to the outer layer 26 and inner layer 28 shownin FIG. 2, FIG. 3 shows an intermediate layer 27 interposedtherebetween. The intermediate layer 27 preferably is a thermoplasticelastomer and more preferably an oil modifiedstyrene-ethylene-butene-styrene block copolymer sold by the ShellChemical Company under the product designation KRATON 62705. Theintermediate layer 27 can also be a blend of from about 99% to about 70%of a thermoplastic elastomer and from about 1% to about 30% of apropylene containing polymer.

[0035] Suitable propylene containing polymers include homopolymers,copolymers and terpolymers of propylene. Suitable comonomers are one ormore α-olefins having from 2 to 17 carbons and most preferably isethylene in an amount by weight from about 1% to about 8% by weight ofthe copolymer. Suitable propylene containing polymers include those soldby Solvay under the tradename FORTILENE and include from about 1.0% toabout 4.0% ethylene by weight of the copolymer.

[0036] Suitable α-olefin containing polymers include homopolymers,copolymers and interpolymers of α-olefins having from 2 to 17 carbons.Suitable ethylene α-olefin copolymers have a density, as measured byASTM D-792, of less than about 0.915 g/cc and are commonly referred toas very low density polylethylene (VLDPE), linear low densitypolyethylene (LLDPE), ultra low density polyethylene (ULDPE) and thelike. In a preferred form of the invention, the ethylene and α-olefincopolymers are obtained using single site catalysts. Suitable catalystsystems, among others, are those disclosed in U.S. Pat. Nos. 5,783,638and 5,272,236. Suitable ethylene and α-olefin copolymers include thosesold by Dow Chemical Company under the AFFINITY tradename, DuPont-Dowunder the ENGAGE tradename, Exxon under the EXACT tradename and PhillipsChemical Company under the tradename MARLEX.

[0037] Suitable polyamides include those selected from a groupconsisting of: aliphatic polyamides resulting from the condensationreaction of di-amines having a carbon number within a range of 2-13,aliphatic polyamides resulting from a condensation reaction of di-acidshaving a carbon number within a range of 2-13, polyamides resulting fromthe condensation reaction of dimer fatty acids, and amide containingcopolymers. Polyamides resulting from a ring opening operation of acyclic amides such as a s-caprolactam is also suitable. In a preferredform of the invention, the polyamide is a dimer fatty acid polyamidesold by Henkel under the tradename MACROMELT. Suitable thermoplasticelastomers of the present invention include styrene and hydrocarboncopolymers, and EPDM. The styrene can be substituted or unsubstitutedstyrene. The styrene and hydrocarbon copolymers can be a block copolymerincluding di-block, tri-block, star block, it can also be a randomcopolymer and other types of styrene and hydrocarbon copolymers that areknown by those skilled in the art. The styrene and hydrocarboncopolymers can also contain various types of the above-identifiedstyrene and hydrocarbon copolymers. The styrene and hydrocarboncopolymers can be functionalized by carboxylic acid groups, anhydridesof carboxylic acids, esters of carboxylic acids, epoxy groups and carbonmonoxide. In a preferred form of the invention, the thermoplasticelastomer of the first layer 22 of the port tube 18 and the inner layer28 of the membrane tube 20 is an SEBS di-block copolymer SEBS copolymer.Such a copolymer is sold by Shell Chemical Company under the tradenameKRATON® FG1924X. The preferred thermoplastic elastomer of the secondlayer 24 of the port tube 18 and the outer layer 26 of the membrane tube20 is an SEBS copolymer. Such a copolymer is sold by, for example, ShellChemical Company under the tradename KRATON® 1660.

[0038] Suitable polyester polyether block copolymers have are sold byDuPont under the tradename HYYTREL and particularly HYTREL 4056

[0039] The term “vinyl lower alkyl esters” include those having theformula set forth in Diagram 1:

[0040] The R in Diagram 1 refers to alkanes having from 1 to 17 carbons.Thus, the term “vinyl lower alkyl esters” includes but is not limited tovinyl methanoate, vinyl acetate, vinyl propionate, vinyl butyrate andthe like. In a preferred form of the invention, the ethylene and vinyllower alkyl ester of the second layer 24 of the port tube 18 and theouter layer 26 of the membrane tube 20 is an ethylene and vinyl acetatecopolymer having from about 12% to about 40% vinyl acetate comonomer byweight of the copolymer. Suitable ethylene and vinyl acetate copolymersare sold by Quantum under the product designations LJE634 and UE697.

[0041] Suitable ABS copolymers include acrylonitrile butadiene styrenetriblock copolymers.

[0042] Suitable cyclic olefin or bridged polycyclic hydrocarboncontaining polymers and blends thereof can be found in U.S. Pat. Nos.5,218,049, 5,854,349, 5,863,986, 5,795,945, 5,792,824; 6,297,322, EP 0291,208, EP 0 283,164, EP 0 497,567 which are incorporated in theirentirety herein by reference and made a part hereof. In a preferred formof the invention, these homopolymers, copolymers and polymer blends willhave a glass transition temperature of greater than 50° C., morepreferably from about 70° C. to about 180° C., a density greater than0.910 g/cc and more preferably from 0.910 g/cc to about 1.3 g/cc andmost preferably from 0.980 g/cc to about 1.3 g/cc and have from at leastabout 20 mole % of a cyclic aliphatic or a bridged polycyclic in thebackbone of the polymer more preferably from about 30-65 mole % and mostpreferably from about 30-60 mole %.

[0043] In a preferred form of the invention, suitable cyclic olefinmonomers are monocyclic compounds having from 5 to about 10 carbons inthe ring. The cyclic olefins can selected from the group consisting ofsubstituted and unsubstituted cyclopentene, cyclopentadiene,cyclohexene, cyclohexadiene, cycloheptene, cycloheptadiene, cyclooctene,cyclooctadiene. Suitable substituents include lower alkyl, acrylatederivatives and the like.

[0044] In a preferred form of the invention, suitable bridged polycyclichydrocarbon monomers have two or more rings and more preferably containat least 7 carbons. The rings can be substituted or unsubstituted.Suitable substitutes include lower alkyl, aryl, aralkyl, vinyl,allyloxy, (meth) acryloxy and the like. The bridged polycyclichydrocarbons are selected from the group consisting of those disclosedin the above incorporated patents and patent applications. Suitablebridged polycyclic hydrocarbon containing polymers are sold by Ticonaunder the tradename TOPAS, by Nippon Zeon under the tradename ZEONEX andZEONOR, by Daikyo Gomu Seiko under the tradename CZ resin, and by MitsuiPetrochemical Company under the tradename APEL.

[0045] Suitable comonomers include α-olefins having from 3-10 carbons,aromatic hydrocarbons, other cyclic olefins and bridged polycyclichydrocarbons.

[0046] It may also be desirable to have pendant groups associated withthe cyclic olefin containing polymers and bridged polycyclic containinghyrdrocarbons. The pendant groups are for compatibilizing the cyclicolefin containing polymers and the bridged polycyclic hydrocarboncontaining polymers with more polar polymers including amine, amide,imide, ester, carboxylic acid and other polar functional groups.Suitable pendant groups include aromatic hydrocarbons, carbon dioxide,monoethylenically unsaturated hydrocarbons, acrylonitriles, vinylethers, vinyl esters, vinylamides, vinyl ketones, vinyl halides,epoxides, cyclic esters and cyclic ethers. The monethylenciallyunsaturated hydrocarbons include alkyl acrylates, and aryl acrylates.The cyclic ester includes maleic anhydride.

[0047] The port tube and the membrane tube are preferably fabricatedusing coextrusion techniques well known to those skilled in the polymerfabrication art. The membrane tube is preferably bonded to the port tubeby dipping the membrane tube in a suitable solvent such as an aromaticsolvent including cyclohexanone, toluene, tetrahydofuran, cumene,xylenes, diethyl benzene, tetralin, decalin and amyl benzene to name afew.

EXAMPLES

[0048] Membrane tubes and port tubes were coextruded having the layeredstructures set forth in the table below. The membrane tubes were dippedin cyclohexanone and were inserted into the membrane tubes in atelescoping fashion to form a closure assembly. The closure assemblieswere tested for bond strength, spike insertion force and spike removalforce.

[0049] The bonding strength was tested by gripping the port tube at oneend of an Instron tester and the membrane tube in the other end andoperating the Instron at a cross head speed of 10 in./min.

[0050] A two layered port tube having an outer and an inner layer wascoextruded. The inner layer had a thickness of 0.006 inches and wasfabricated from SEBS. The outer layer had a thickness of 0.026 inchesand was fabricated from a polymer blend by weight of the outer layer of35% polypropylene/5% ultra low density polyethylene/30% dimer fatty acidpolyamide/30% SEBS with maleic anhydride functionality.

[0051] A three layered membrane tube was coextruded having an innerlayer, a core layer and an outer layer. The inner layer is a polymerblend by weight 30% polypropylene/35% dimer fatty acid polyamide/35%SEBS. The core layer was a blend of 85% SEBS and 15% polypropylene. Theouter layer was 45% SEBS and 55% polypropylene. The inner layer had athickness of 0.003 inches, the core layer 0.023 inches and the outerlayer 0.006 inches.

[0052] Polymeric sheeting was extruded from a blend by weight of 10%dimer fatty acid polyamide, 35% ultra low density polyethylene, 45%polypropylene and 10% SEBS with maleic anhydride functionality.

[0053] Two rectangularly-shaped sheets of the polymeric sheeting wereplaced into registration and sealed along 3 peripheral edges to define apouch. A port tube segment was inserted into an open end of the pouchand was heat sealed therein while sealing the final peripheral edge todefine a container. A membrane tube segment was dipped intocyclohexanone and inserted in a telescoping fashion into the port tubesegment.

[0054] The container was bolted down proximate a mechanical tester. Theport tube was attached to a spike attached to a cross-head of themechanical tester. The cross-head speed of the tester was set at 20in/min. The cross-head was set to achieve the desired spike insertiondepth in the port tube. The tester allowed for measuring the spikeinsertion force and the spike removal force. The average spike insertionvalue after 50 tests was 13.31 lbf. The average spike removal force for50 tests was 10.37 lbf. These measurements were made after the spikedwelled in the membrane tube for 24 hours.

[0055] The tester was also used to determine the pull force necessary toremove the port tube from the container or to otherwise damage thecontainer or port tube. The port tube was inserted into the tester withthe container bolted down. The average pull force for 28 tests was 30.04lbf. This test was conducted prior to steam sterilizing the container.The value for 30 test after the container was steam sterilized was 42.68lbf.

[0056] The components of individual tubing layers are designated asfollows in Table 1:

[0057] I=a blend by weight of the following components: of 40%polypropylene, 40% by weight ULDPE, 10% dimer fatty acid polyamide and10% SEBS.

[0058] II=a blend by weight of the following four components: 38%polyester polyether block copolymer (Hytrel), 2% polypropylene, 10% EVAand 50% SEBS.

[0059] III=a blend by weight of the following five components: 27%polyester polyether block copolymer, 1% polypropylene, 7% EVA, 35% SEBSand 30% ABS.

[0060] IV=Shell Kraton KG 2705

[0061] V=a blend by weight of the following components: 45%polypropylene, 35% ULDPE, 10% dimer fatty acid polyamide and 10% SEBS.

[0062] The tubings layers are specified from outside layer, intermediatelayer and inside layer.

[0063] The results of these tests are reported in Table 1 below.Membrane Spike Port tube Tube Bond strength Insertion Spike removal I/IIII/IV/I 25-30 24 19 I/III III/IV/I 50-55 25 30 12

[0064] While specific embodiments have been illustrated and described,numerous modifications come to mind without departing from the spirit ofthe invention and the scope of protection is only limited by the scopeof the accompanying claims.

What is claimed is:
 1. A multiple layered non-PVC containing tubing structure comprising: a first layer of a polymer blend of (a) from about 30% to about 50% by weight of the first layer a first polyolefin selected from the group consisting of polypropylene and polypropylene copolymers, (b) from about 0% to about 50% by weight of the first layer a second polyolefin of an α-olefin containing polymer; (c) from about 0% to about 40% by weight of the first layer of a radio frequency susceptible polymer selected from the group consisting of polyamides, ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, polyureas, ethylene vinyl acetate copolymers with a vinyl acetate comonomer content from 18-50% by weight of the copolymer, ethylene methyl acrylate copolymers with methyl acrylate comonomer content from 18%-40% by weight of the copolymer, ethylene vinyl alcohol with vinyl alcohol comonomer content from 15%-70% by mole percent of the copolymer; (d) from about 0% to about 40% of a first thermoplastic elastomer; and a second layer of a non-PVC containing material of a multiple component polymer blend.
 2. The tubing of claim 1 wherein the second layer is coaxially mounted within the first layer.
 3. The tubing of claim 1 wherein the first layer is coaxially mounted within the second layer.
 4. The tubing of claim 1 wherein the polymer blend comprises by weight of the second layer: from about 25% to about 55% by weight of a second thermoplastic elastomer, from about 20% to about 45% of a polyester polyether block copolymer, from about 0% to about 15% ethylene copolymerized with vinyl lower alkyl esters, from about 0% to about 10% of a propylene containing polymer and from about 0% to about 35% of a polymer selected from the group consisting of acrylonitrile butadiene styrene block copolymer, styrene ethylene butene copolymer, styrene acrylonitrile copolymer, cyclic olefin containing polymers and bridged polycylic olefin containing polymers.
 5. The tubing of claim 1 wherein the polyamide is selected from a group consisting of aliphatic polyamides resulting from the condensation reaction of di-amines having a carbon number within a range of 2-13, aliphatic polyamides resulting from a condensation reaction of di-acids having a carbon number within a range of 2-13, ring opening reactions of cyclic amides, polyamides resulting from the condensation reaction of dimer fatty acids, and amide containing copolymers.
 6. The tubing of claim 1 wherein the polyamide is a dimer fatty acid polyamide.
 7. The tubing of claim 1 wherein the first polyolefin is a propylene copolymerized with a monomer selected from the group consisting of α-olefins having from 2-17 carbons.
 8. The tubing of claim 7 wherein the first polyolefin is a propylene and ethylene copolymer having an ethylene content of from about 1% to about 8% by weight of the first polyolefin.
 9. The tubing of claim 1 wherein the first thermoplastic elastomer is selected from the group consisting of a first styrene and hydrocarbon copolymer.
 10. The tubing of claim 9 wherein the first thermoplastic elastomer is maleic anhydride functionalized.
 11. The tubing of claim 10 wherein the first thermoplastic elastomer is a styrene-ethylene-butene-styrene block copolymer.
 12. The tubing of claim 11 wherein the first thermoplastic elastomer is selected from the group consisting of styrene and hydrocarbon diblock copolymers, styrene and hydrocarbon block copolymers and styrene and hydrocarbon star block copolymers.
 13. The tubing of claim 10 wherein the first thermoplastic elastomer is functionalized with a group selected from the group consisting of carboxylic acid, esters of carboxylic acids, anhydrides of carboxylic acids, epoxides, and carbon monoxide.
 14. The tubing of claim 13 wherein the first thermoplastic elastomer is maleic anhydride functionalized.
 15. The tubing of claim 4 wherein the second styrene and hydrocarbon copolymer is selected from the group consisting of styrene and hydrocarbon diblock copolymers, styrene and hydrocarbon triblock copolymers, styrene and hydrocarbon star block copolymers and blends of the same.
 16. The tubing of claim 15 wherein the second thermoplastic elastomer is a styrene-ethylene-butene-styrene block copolymer.
 17. The tubing of claim 1 wherein the second polyolefin is an α-olefin copolymerized with a ethylene monomer.
 18. The tubing of claim 17 wherein the second polyolefin is an ethylene and α-olefin copolymer.
 19. The tubing of claim 18 wherein the ethylene and α-olefin copolymer is obtained using a single site catalyst.
 20. A multiple layered non-PVC containing tubing structure comprising: a first layer of a non-PVC containing multiple component polymer blend; and a second layer attached to the first layer of a non-PVC containing material of multiple component polymer blend of from about 25% to about 55% by weight of a first thermoplastic elastomer, from about 20% to about 45% of a polyester polyether block copolymer, from about 0% to about 15% ethylene copolymerized with vinyl lower alkyl esters, from about 0% to about 10% of a propylene containing polymer and from about 0% to about 35% of a component selected from the group consisting of acrylonitrile butadiene styrene block copolymer, styrene ethylene butene copolymer, styrene acrylonitrile copolymer, cyclic olefin containing polymers and bridged polycyclic olefin containing polymers.
 21. The tubing of claim 20 wherein the second layer is coaxially mounted within the first layer.
 22. The tubing of claim 20 wherein the first layer is coaxially mounted within the second layer.
 23. The tubing of claim 20 wherein the first layer is a polymer blend comprising by weight of the first layer: (a) from about 30% to about 50% of a first polyolefin selected from the group consisting of polypropylene and polypropylene copolymers, (b) from about 0% to about 50% of a second polyolefin of an α-olefin containing polymer, (c) from about 0% to about 40% of a radio frequency susceptible polymer selected from the group consisting of polyamides, ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, polyureas, ethylene vinyl acetate copolymers with a vinyl acetate comonomer content from 18-50% by weight of the copolymer, ethylene methyl acrylate copolymers with methyl acrylate comonomer content from 18%-40% by weight of the copolymer, ethylene vinyl alcohol with vinyl alcohol comonomer content from 15%-70% by mole percent of the copolymer; and (d) from about 0% to about 40% of a second thermoplastic elastomer.
 24. The tubing of claim 20 wherein the first thermoplastic elastomer is a first styrene and hydrocarbon copolymer.
 25. The tubing of claim 24 wherein the first styrene and hydrocarbon copolymer is selected from the group of styrene and hydrocarbon diblock copolymers, styrene and hydrocarbon triblock copolymers, and styrene and hydrocarbon star block copolymers.
 26. The tubing of claim 25 wherein the first thermoplastic elastomer is a styrene-ethylene-butene-styrene block copolymer.
 27. The tubing of claim 26 wherein the first thermoplastic elastomer is a first styrene-ethylene-butene-styrene block copolymer.
 28. The tubing of claim 20 wherein the vinyl lower alkyl esters is selected from the group consisting of vinyl methanoate, vinyl acetate, vinyl propionate, and vinyl butyrate.
 29. The tubing of claim 28 wherein the vinyl lower alkyl ester is vinyl acetate.
 30. The tubing of claim 28 wherein the ethylene and vinyl lower alkyl ester is an ethylene and vinyl acetate copolymer having a vinyl acetate content from about 12% to about 32% by weight of the copolymer.
 31. The tubing of claim 20 wherein the propylene containing polymer is propylene copolymerized with a monomer selected from the group consisting of α-olefins having from 2-17 carbons.
 32. The tubing of claim 31 wherein the propylene containing polymer is a propylene and ethylene copolymer having an ethylene content of from about 1% to about 6% by weight of the copolymer.
 33. The tubing of claim 23 wherein the second polyolefin is obtained using a single-site catalyst. 